Neoplasms

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Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

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Colonic Diseases

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alpha-Tocopherol

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Omega 3 Fatty Acid

Tocopherol

Tocotrienol

Cola

2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.

2 infusions of 2ml/kg, one the night before surgery and one the day after surgery

2 infusions, 2 ml/kg, one the night before operation and one the day after operation

Omegaven

Placebo

A.P.J. Houdijk, Dr.

Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled inflammatory response, however may lead to catabolism, tissue damage and organ failure. Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells, they trigger intracellular signalling pathways that result in a less pro-inflammatory response. They modify gene and protein expression, modulate membrane protein activity and act as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and wound healing.

The investigators hypothesize that the perioperative administration of intravenous omega-3 fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby reducing the postoperative inflammatory response and improving erythrocyte function in patients undergoing colorectal surgery.

Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function

Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer

Length of hospital stay and occurence of surgical site infection, abscess, urinary tract infection, pneumonia, anastomotic leakage, need for Intensive Care Unit admission, Systemic Inflammatory Response Syndrome, Multi Organ Failure, any adverse events.

Neuropsychological examination using a reading test, an auditory verbal learning test, WAIS III figure series and trail making tests.

Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine IL-6, measured in ng/ml.

Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine TNF-α (tumor necrosis factor-α), and the anti-inflammatory cytokine IL-10 (interleukine-10), both measured in ng/ml.

Erythrocyte deformability and aggregation measured by LORRCA (laser assisted optical rotational red cell analyzer)

White blood cell count, C-reactive protein and cytokine levels (Interleukine-6, Tumor Necrosis Factor-α and Interleukine-10) in serum.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function	NCT02231203	Colon Cancer	Omegaven Placebo	60 Years - 80 Years	Medical Center Alkmaar
Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function	NCT02231203	Colon Cancer	Omegaven Placebo	60 Years - 80 Years	Medical Center Alkmaar

Spots Global Cancer Trial Database for postoperative inflammatory response